# K980005: Manan D Bag

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Jan 30, 1998 after 28 days
- Product code: EXF (Bag, Bile Collecting)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963849 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961986: Manan D Bag, Manan Medical Products, Inc. (1997) Summary page 1.
- K963849: Manan D Bag, Manan Medical Products, Inc. (1996) Summary page 1.

## Indications for use
The Manan™ D Bag is for nephrostomy, abcess and other drainage collection.

Source page: https://510kreport.com/device/K980005
Methodology: https://510kreport.com/methodology